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Clinical Services Operational Specialist

Clinical Services Operational Specialist

Abbott

5 years

0 Lacs

mumbai maharashtra india

Posted:2 days ago| Platform:

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Skills Required

management training support integrity checks reporting maintenance documentation learning updating dashboard development pharmacovigilance ethics compliance data analytics software excel

Work Mode

On-site

Job Type

Full Time

Job Description

Primary Job Function

The Clinical Services Operational Specialist supports the efficient and compliant execution of Global Program Management activities to internal and external standards by supporting the Clinical Services Team in various projects.

Core Job Responsibilities

CTMSPreparation of Training Material for CTMSProviding user support as CTMS subject matter expertSupport CTMS team in all activities required for system upgrades or for release of new CTMS modulesHandle general CTMS requestsData integrity and validation checks checks to ensure information is complete for reportingTrial DisclosureSubject matter expert for Trial DisclosureResponsible for disclosure of studies in the various disclosure registers as requiredeTMFSubject matter expert for document management systemEnsure system is aligned with the SOPUpdate TMF according to DIA eTMF release notesTrainingSupport implementation and maintenance of documentation and training systems within medical officeActs as super user for selected systemsMaintain CTMS matrixCTMS Training maintenance and generation of new training courses a s neededLiaising with Learning Management System coordinator for training assignmentSOPContribute to reviewing and updating SOP and processes as requiredDashboardSupport in creating dashboards in PowerBI/ other BI applications

Position Accountability / Scope :

Responsible for CTMS Training Material Development
Responsible for supporting dashboard creation as per the needs
Responsible for eTMF, Trial Disclosure
Responsible for quality control
Internal stakeholders Medical Office (Medical Affairs, Clinical Development and Pharmacovigilance), Quality Assurance, Regulatory Affairs, Office of Ethics and Compliance, global, regional and local
External stakeholders business partners (contractors, consultants, vendors)

Minimum Education

Masters in Science / Computers /Advance Data Analytics degree or equivalent by experience

Experience :

At least 5-years’ experience in pharmaceutical industry/ IT software industry/ Data Analytics
Experience with working in a Global fast paced environment
Attention to detail, organized, capable of multi-tasking, capable of working independently
Proficient in MS office applications especially Excel and Word
Experience of records management/ quality control/ system management preferable
Fluent in English

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Clinical Services Operational Specialist